Notice of Retraction and Replacement. Ellison-Barnes et al. Trends in Obesity Prevalence Among Adults Aged 18 Through 25 Years, 1976-2018. <i>JAMA</i>. 2021;326(20):2073-2074
Authors: Alejandra Ellison-Barnes, Sara Johnson, Kimberly Gudzune
Journal: JAMA (2023)

In Reply In response to the Letter by Mr Smith and colleagues, we agree that studies of representative patient populations are important, but we challenge the notion that our results cannot be applied to a general population of individuals with psoriasis because only 36.3% of patients were female.The consideration when assessing the applicability of the results should be whether the sample size is sufficient to make precise determinations of efficacy and safety rather than if the percentage of females in the trials match the general psoriasis population, although the latter is also important.Our study included a sizable representation of 320 female patients with psoriasis (36.3%).Indeed, the corresponding author of the Letter to which we are responding was coauthor of a recent large psoriasis study in which only 31% to 32% of patients were female. 1 Additionally, in the study cited by Smith and colleagues that assessed sex differences in severity of psoriasis, 40% of the patients were female, and the severity of psoriasis in females as assessed by the Psoriasis Area and Severity Index (PASI) scores was lower than males. 2 This study also reported that a lower percentage of female patients sought specialist care for their psoriasis. 2In a pooled analysis of the female subgroup of patients in DERMIS-1 and DERMIS-2, Investigator Global Assessment success at week 8 was achieved in 38.0% of females treated with 0.3% roflumilast cream vs 5.2% in the vehicle group (P < .001),and a 75% reduction from baseline in PASI scores was achieved in 38.0% of roflumilast-treated females vs in 6.3% of vehicletreated females (P < .001).No clinically meaningful differences in adverse events between females and males were observed in our study.This subgroup analysis of female patients was consistent with the overall results reported in the DERMIS-1 and DERMIS-2 trials. 3 Recruiting pediatric psoriasis trial participants has been challenging, and we agree with many of the points made by Smith and colleagues.For example, the corresponding author was lead author on an article in which less than 0.2% of patients with psoriasis (19 of 10 000) were pediatric. 4The limitations in the pediatric data within the DERMIS trials were highlighted in our article. 3Furthermore, additional trials assessing 0.3% roflumilast cream in patients younger than 18 years (NCT04279119, NCT04655313, NCT04746911) have been completed and will be reported in future publications.Because roflumilast cream, 0.3%, is now approved for use in patients aged 12 years or older with psoriasis, possible regimens for chronic plaque psoriasis that could be tested include both topical roflumilast and topical corticosteroids.However, such a trial would need to be limited in duration and location of application because topical corticosteroids and topical corticosteroid combination products are not recom-mended for prolonged use due to potential adverse effects.A key potential advantage of roflumilast cream, 0.3%, is that it can be used long-term and on sensitive areas including the face and genital and intertriginous regions.